To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.

Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

240

Study Completion Date:

May 1990

Detailed Description:

Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.

Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.

Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).

Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days.

Concurrent Treatment:

Excluded:

Radiation therapy for treatment of Kaposi's sarcoma lesions.

The following patients will be excluded from the study:

Patients with a history of any AIDS-defining opportunistic infection.

Patients with any of the following constitutional symptoms with no etiology established:

Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent.

Patients with a history of other systemic malignancies or lymphomas.

Prior Medication:

Excluded:

Systemic antineoplastic chemotherapy.

Zidovudine (AZT).

Excluded within 30 days of study entry:

Antiretroviral agents.

Immunomodulating agents.

Prophylaxis for Pneumocystis carinii pneumonia.

Prophylaxis for herpes simplex virus infections.

Any other experimental therapy.

Prior Treatment:

Excluded within 30 days of study entry:

Any experimental therapy.

Active substance abuse.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000994